The new heart device's FDA approval stems from the results of a global
series of studies involving the Resolute DES, which showed consistently
powerful clinical performance across a broad spectrum of patients –– including
those with diabetes, a common contributor to coronary artery disease
that complicates treatment. The Resolute DES uses the same
drug-and-polymer combination as the Resolute Integrity DES.

The Resolute Integrity DES builds on the success of the market-leading
Integrity bare metal stent. The Integrity platform's rapid adoption in
the United States is the result of a proprietary engineering advance
called continuous sinusoid technology (CST).

CST encompasses one continuous, single strand of wire that is molded
into a sinusoidal wave and then wrapped in a helical pattern and
laser-fused at certain points, making each stent comparable to a
flexible spring.

“The Resolute Integrity DES offers several notable benefits, starting
with outstanding deliverability, which means it's exceptionally easy to
navigate the stent on the delivery system through the coronary
vasculature to the narrowed arterial segment that requires treatment,”
explained Martin B. Leon, M.D., director of the center for
interventional vascular therapy at New York-Presbyterian/Columbia
University Medical Center, founder and chairman emeritus of the
Cardiovascular Research Foundation, and a principal investigator (PI) of
the RESOLUTE US clinical study. “Its approval by the FDA is based on the
impressive performance of the Resolute DES in a wide variety of
patients. With the device's compelling combination of deliverability,
efficacy and safety, not to mention that it is the first DES approved
for patients with diabetes, the Resolute Integrity DES promises to gain
rapid acceptance in cath labs nationwide.”

Clinical PerformanceThe global RESOLUTE clinical program
consisted of a large randomized controlled trial and a series of
confirmatory single-arm studies involving nearly 250 sites in 32
countries. In total, the program enrolled more than 5,100 patients who
received a Resolute DES; about a third (1,535) of these patients had
diabetes, a proportion that mirrors the U.S. patient mix.

RESOLUTE US enrolled 1,402 patients across 128 U.S.-based clinical trial
sites. It was led by Dr. Leon and his co-PIs: Laura Mauri, M.D., chief
scientific officer of the Harvard Clinical Research Institute and an
interventional cardiologist at Brigham and Women's Hospital in Boston;
andAlan Yeung, M.D., director of interventional cardiology at
Stanford University School of Medicine in Palo Alto, Calif.

At one year of follow-up in RESOLUTE US, the results included low rates
of target lesion failure (TLF, 4.7%), clinically-driven target lesion
revascularization (TLR, 2.8%) and definite/probable stent thrombosis
(def/prob ST, 0.1%). These results were achieved despite 34 percent of
the patients in the study having diabetes, which typically drives higher
event rates.

One year of follow-up in a pre-specified analysis of patients with
diabetes who received a Resolute DES as participants in the Resolute
clinical program also demonstrated low rates of TLF (6.6%), TLR (3.4%)
and def/prob ST (0.3%).

In two separate large randomized controlled trials, the Resolute DES
matched the safety and effectiveness of Abbott Laboratories' Xience V®
DES, which represents the market-leading DES platform in the United
States.

The Resolute All-Comers study, sponsored by Medtronic, enrolled nearly
2,300 patients at 17 centers and was led by Prof. Patrick Serruys, M.D.,
Ph.D., director of the Thoraxcenter at Erasmus University in Rotterdam,
the Netherlands; Prof. Stephan Windecker, M.D., with University Hospital
in Bern, Switzerland; and Prof. Sigmund Silber, M.D., of the Heart
Catheterization Centre in Munich, Germany. The one- and two-year results
of RESOLUTE All Comers were published in The New England Journal of
Medicine and The Lancet, respectively.

While not part of the FDA dataset, the TWENTE study, supported jointly
by Medtronic and Abbott Laboratories, enrolled nearly 1,400 patients at
a single center and was led by Prof. Clemens von Birgelen, M.D., Ph.D.,
co-director of the Department of Cardiology at Thoraxcentrum Twente and
professor of cardiology at the University of Twente in the Netherlands.
Prof. von Birgelen presented the one-year results of TWENTE at the 2011
Transcatheter Cardiovascular Therapeutics (TCT) meeting. The results are
also reported in a recent issue of the Journal of the American
College of Cardiology.

“The new Resolute Integrity DES comes to U.S. cath labs with compelling
clinical evidence and a highly differentiated stent platform,” said Sean
Salmon, president of Medtronic's coronary and renal denervation
business. “Our next-generation zotarolimus-eluting coronary stent has
gained wide global acceptance for its remarkable ability to successfully
meet clinical and anatomic challenges that interventional cardiologists
confront in their everyday practice. We are excited to provide this
important advanced technology to U.S. patients and practitioners.”

With the approval of the Resolute Integrity DES, U.S. patients with both
CAD and diabetes now have access for the first time to a medical device
that has been approved by the FDA as a treatment option specifically
studied and clinically validated for their particularly complex and
potentially life-threatening health conditions. Historically patients
with diabetes who undergo PCI have been a difficult-to-treat patient
population. They tend to have smaller and often tortuous arteries,
longer lesions, diffuse disease and a higher rate of treatment failures
including relatively high rates of repeat procedures and stent
thrombosis.

U.S. LaunchThe U.S. release of the Resolute Integrity DES
also marks the first major product launch to leverage Medtronic's entire
U.S. Cardiac and Vascular Group (CVG) sales force, which includes nearly
3,000 field representatives whose collective objective is to serve the
needs of hospital systems, integrated delivery networks and individual
hospital administrators.

“No other medical device company has a U.S. field footprint as robust as
Medtronic,” said Mike Coyle, president of Medtronic's CVG. “We intend to
use the launch of the Resolute Integrity DES to demonstrate the impact
that our unrivaled scale can deliver for physicians, hospitals and
patients looking for safe, effective and cost-effective solutions for
cardiac and vascular diseases.”

In collaboration with leading clinicians, researchers and scientists,
Medtronic offers the broadest range of innovative medical technology for
the interventional and surgical treatment of cardiovascular disease and
cardiac arrhythmias. The company strives to offer products and services
that deliver clinical and economic value to healthcare consumers and
providers worldwide.

ABOUT MEDTRONICMedtronic, Inc. (www.medtronic.com),
headquartered in Minneapolis, is the global leader in medical technology ––
alleviating pain, restoring health and extending life for millions of
people around the world.

Any forward-looking statements are subject to risks and uncertainties
such as those described in Medtronic's periodic reports on file with the
Securities and Exchange Commission. Actual results may differ materially
from anticipated results.